NCT06615102 Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II
| NCT ID | NCT06615102 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Universität Münster |
| Condition | Cardiac Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,022 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,022 participants in total. It began in 2025-03-31 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study intervention focuses on exploring the use of angiotensin II as a primary vasopressor compared to norepinephrine in cardiac surgery patients to investigate whether angiotensin II can reduce the occurrence of moderate/severe acute kidney injury (AKI). Despite its potential, as suggested by trials involving surgical patients, there is currently no human data confirming its effectiveness in preventing moderate/severe AKI in this context. The intervention aims to address this gap by evaluating angiotensin II's impact compared to norepinephrine.
Eligibility Criteria
Inclusion Criteria: 1. Cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, or combined CABG/valve surgery 2. Elevated risk of AKI as predicted by a score ≥ 1.5 on the following scale: 1. hemoglobin \< 130g/l = 2 2. creatinine \> 1.1 mg/dl = 2 3. age \> 70 years =1.5 4. New York Heart Association Classification (NYHA) 4 =1.5 5. Body Mass Index (BMI) \> 30 =1.5 3. Adult ≥ 18 years 4. Written informed consent Exclusion Criteria: 1. Major aortic surgery (aortic arch replacement), transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement 2. Already receiving inotropic/vasopressor support before surgery 3. Dialysis dependent 4. Pre-existing AKI within the last 30 days 5. Pre-existing chronic kidney injury with an eGFR\<20 ml/min/1.73m2 6. Pre-existing significant hypertension (persistent SBP \> 180mmHg) 7. Significant pulmonary hypertension (ePSAP \> 70mmHg, mPAP \> 40mmHg) with right ventricular systolic dysfunction (graded more severe than mild) 8. Hypersensitivity to the active substance or to any of the excipients 9. Pregnancy (a negative pregnancy test for women of childbearing age) or breastfeeding women 10. Persons with any kind of dependency on the investigator or employed by the sponsor/investigator 11. Participation in another interventional trial within the last three months that investigates kidney function
Contact & Investigator
Alexander Zarbock, MD
PRINCIPAL INVESTIGATOR
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy
Frequently Asked Questions
Who can join the NCT06615102 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06615102 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,022 participants.
Is NCT06615102 currently recruiting?
Yes, NCT06615102 is actively recruiting participants. Contact the research team at PAN-AKI@ukmuenster.de for enrollment information.
Where is the NCT06615102 trial being conducted?
This trial is being conducted at Berlin, Germany, Bonn, Germany, Mainz, Germany, Münster, Germany.
Who is sponsoring the NCT06615102 clinical trial?
NCT06615102 is sponsored by Universität Münster. The principal investigator is Alexander Zarbock, MD at University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy. The trial plans to enroll 1,022 participants.